Forlenget godkjenning av Pythium oligandrum stamme M1 i plantevernmidler

Tittel

Kommisjonens gjennomføringsforordning (EU) 2022/2314 av 25. november 2022 om forlengelse av godkjenningen av det aktive stoffet Pythium oligandrum stamme M1 i samsvar med europaparlaments- og rådsforordning (EF) nr. 1107/2009 om markedsføring av plantevernmidler, og om endring av vedlegget til kommisjonens gjennomføringsforordning (EU) nr. 540/2011

Commission Implementing Regulation (EU) 2022/2314 of 25 November 2022 renewing the approval of the active substance Pythium oligandrum strain M1 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011

Siste nytt

Kommisjonsforordning publisert i EU-tidende 28.11.2022

Nærmere omtale

BAKGRUNN (fra kommisjonsforordningen)

(1) Commission Directive 2008/113/EC included Pythium oligandrum strain M1 as an active substance in Annex I to Council Directive 91/414/EEC .

(2) Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 .

(3) The approval of the active substance Pythium oligandrum strain M1, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 30 April 2023.

(4) An application for the renewal of the approval of the active substance Pythium oligandrum strain M1 was submitted to the rapporteur Member State in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 within the time period provided for in that Article.

(5) The applicant submitted the supplementary dossiers required in accordance with Article 6 of Implementing Regulation (EU) No 844/2012 to the rapporteur Member State, the co-rapporteur Member State, the Commission and the European Food Safety Authority (‘the Authority’). The application was found to be complete by the rapporteur Member State.

(6) The rapporteur Member State prepared a draft renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the Authority and the Commission on 26 September 2018.

(7) The Authority circulated the draft renewal assessment report to the applicant and to the Member States for comments, launched a public consultation on it and forwarded the comments received to the Commission. The Authority also made the supplementary summary dossier available to the public.

(8) On 8 October 2020, the Authority communicated to the Commission its conclusion on whether Pythium oligandrum strain M1 can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

(9) The Commission presented a renewal report and a draft Regulation regarding Pythium oligandrum strain M1 to the Standing Committee on Plants, Animals, Food and Feed on 18 May 2022 and 15 July 2022, respectively.

(10) The Commission invited the applicant to submit its comments on the conclusion of the Authority and, in accordance with Article 14(1), third paragraph, of Implementing Regulation (EU) No 844/2012 , on the renewal report. The applicant submitted its comments, which have been carefully examined.

(11) It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance Pythium oligandrum strain M1 that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.

(12) It is therefore appropriate to renew the approval of Pythium oligandrum strain M1.

(13) In accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to provide for certain conditions. It is, in particular, appropriate to require that Member States, when assessing applications for authorisations of products containing Pythium oligandrum strain M1, pay particular attention to the specification of the technical material and to the protection of operators and workers, and foresee risk mitigation measures such as personal and respiratory protective equipments to address the risks of sensitisation or physical effects on the respiratory system that may be caused by the micro-organism.

(14) Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

(15) Commission Implementing Regulation (EU) 2022/378 extended the approval period of Pythium oligandrum strain M1 to 30 April 2023 in order to allow the renewal process to be completed before the expiry of the approval period of that active substance. However, given that a decision on renewal has been taken ahead of that extended expiry date, this Regulation should apply earlier than that date.

(16) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

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25.10.2022
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24.11.2022
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18.12.2022

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